Shortened vs standard chemotherapy combined with immunotherapy for the initial treatment of patients with high tumor burden Follicular Lymphoma A randomized, open label, phase III study by Fondazione Italiana Linfomi.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511636-27-00

Acronym

FIL_FOLL19

Enrollment

602

Registered

2024-11-27

Start date

2021-12-01

Completion date

Unknown

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular Lymphoma

Brief summary

Progression-free survival (PFS).

Detailed description

Overall Survival (OS);, Event Free Survival (EFS), Response rate (overall [ORR] and complete [CRR], according to Cheson 2014);, Molecular response evaluated by polymerase chain reaction (PCR) assessment of Bcl2/IgH rearrangement;, Safety of the treatment according to the current version of the CTCAE, Quality of life evaluated through the Patient reported outcomes (PROs) by means of the FACT-Lym questionnaire

Interventions

DRUGRITUXIMAB

DRUGDOXORUBICIN

DRUGVINCRISTINE

DRUGPREDNISONE

DRUGOBINUTUZUMAB

DRUGBENDAMUSTINE

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS).	—

Secondary

Measure	Time frame
Overall Survival (OS);, Event Free Survival (EFS), Response rate (overall [ORR] and complete [CRR], according to Cheson 2014);, Molecular response evaluated by polymerase chain reaction (PCR) assessment of Bcl2/IgH rearrangement;, Safety of the treatment according to the current version of the CTCAE, Quality of life evaluated through the Patient reported outcomes (PROs) by means of the FACT-Lym questionnaire	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026